Archives for posts with tag: actipatch

I’m saving a couple excellent comments for posterity and reference posted on the IHUB board. If you read this blog, I base my interest in this stock on primary research articles, and have analyzed them to the point of putting the data into my own statistical software (JMP). We actually got The Oxford Journal to issue a correction for one of their published charts based on my analysis of their data. For brass tacks, real time analysis of BIEL related FDA matters, IHUB is a good source. People reach out to the company, as seen below.

I’m pretty stoked about the new 510K submission for Expanded Clearance. I have a very vivid vision of going to Sam’s Club and buying one of those big First Aid kits and finding a couple of ActiPatches in it. I’m not too visionary, but sometimes a little ahead of the curve. People are going to go through the hoops some of have jumped through and start seeing the potential of this treatment.

If the Bayer/Dr. Scholl’s deal comes though, then you have that and the Expanded Clearance Application (world’s first electronic aspirin) in the mix. Explosive.

I post the comments below because I agree with them based on my research. This is complicated stuff

 

Courtesy of Markjohn

“Here is a reply about the word “trsitional” (sic) in the press release-

From Sree Koneru

Thank you for your message. The 510(k) that was filed does combine indications from the previous 510(k), which is why we are asking for “expanded” indications. The word “traditional” in the 510(k) is just to indicate the type of application prepared, as there are only three types. Seeking expanded indications automatically requires a “traditional” 510(k), since the other two types are for device modifications etc.”

Courtesy of Dewmboom.

“I am glad you looked at this and I did not want to confuse people with too much information here. I have looked at this very carefully well before now and here what I found.

If you look at the definitions of all 510Ks as well as the EAP. The circumstances of the Actipatch does not fit any of the definitions.

For the traditional 510K, Biel already waited months to get the FDA approval for knee and foot. So, they paid their dues their. As for the specifics of the abbreviated and special 510K, they do not fit the exact definition for why Biel is submitting when you look at them. The EAP does not apply because the Actipatch is not a life threatening breakthrough technology.

The only thing we know is that Biel has a pre-meeting with the FDA, and during that meeting the FDA gave them guidance on how to submit for expedited processing knowing the circumstances, evidenced by this quote:

Quote:


Dr. Koneru, who led the discussion, expressed confidence in the FDA’s constructive feedback. “We are pleased that the FDA viewed our data and statistical methods favorably. They have provided guidance on how to combine the back-pain study results, along with our previously cleared 510(k), into a single 510(k) submission for obtaining expedited expanded market clearance.”, he said.


As I indicated before, the FDA drilled this to the nth degree already and there is no good reason for it to take any longer than 30 days. Biel is not making any changes to the device, they are just showing a clinical trial for back pain to expand the approval into full body muscle and pain.

http://www.bielcorp.com/bioelectronics-receives-fda-pre-submission-approval-for-its-relief-of-musculoskeletal-pain-market-clearance-application/ ”

speakerhim

“My only guess as to why a traditional path was taken(if it was at all) is that the general actipatch for pain could have been guided to a traditional route to secure a solid foundation for all other applications for expedited clearance, including recoveryrx, allay, maxofacial, etc… ”

 

All interesting comments. We are dealing with a completely new portable approach to Pain Management. There is going to be some confusion every step of the way, but the important thing is the gamechanger got filed, and filed by a group with a proven history of success (3 FDA approvals, NHS in the UK, and the BRAUN deal.

20160713_14282320160713_142828

 

 

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Okay, so my post about BIEL on Twitter sort of got upstaged here. This got picked up by Yahoo pretty quick. I will do the math for you–7x 160,000=1,120,000 units a years just got sold. I had to ask the Gifted kid to do the math for me, because I can’t do math when I get giddy.

Also, FDA, put this in your pipe and smoke it. Next step is Germany announces it will reimburse for the ActiPatch the way the United Kingdom has through its NHS. The FDA better get it in gear. Margaret Hamburg, the Renaissance Hedge Fund, Hillary’s grifting out FDA top slots to her political stooges—those days are over. Trump doesn’t know enough about how government really works to know how much money he is leaving on the table by not taking the opioid payoff money. Hillary never would have let this happen.

#BRAUN!!!!

 

https://finance.yahoo.com/news/b-braun-medical-includes-bioelectronics-120000701.html

 

B. Braun Medical Includes BioElectronics ActiPatch Medical Device In Its Same Day Knee and Hip Surgical Program

GlobeNewswire

FREDERICK, MD., May 31, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), maker of advanced medical devices announces that B. Braun Ltd, of Sheffield, UK has recently completed development of its same day surgical TOTAL Pathway program for joint replacements which includes BioElectronics medical devices. The program is being launched by B. Braun’s UK Group to improve care and reduce the UK healthcare cost of its 160,000 annual hip and knee replacement procedures.

The “fast-track” same day hip and knee replacements are being supported by hospital physiotherapy teams visiting the patient at home and communicating using a specialized wireless tablet. Each patient will be given an ActiPatch medical device and a prescription for 6 additional ActiPatch devices. A similar program is being implemented for spinal surgeries.

Phil Cleary, Senior Product Group Manager, stated that “our TOTAL Pathway program http://media.cdn.edgecdn.net/zvts/1486044207/videos/videodb/2512/videodb_2512_31266_9406897_16x9.mp enhances our commitment to patient safety, post-operative care, as well as significantly reducing healthcare costs and hospital stays.” Treating post-surgical pain requires a multifaceted approach. In trials, ActiPatch was well received and produced positive outcomes. We look forward to making this program a success, in the UK and other countries where B. Braun operates.

About BioElectronics Corporation

BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: For more information, please visit www.bielcorp.com.

About B. Braun Medical Ltd B. Braun Medical Ltd, UK, https://www.bbraun.co.uk/ is a member of the B. Braun Group, https://www.bbraun.com/en.html one of the world´s leading healthcare companies. On an international level, B. Braun’s 54,000 employees are in 60 countries and are separated into additional divisions for hospital care, surgical products, outpatient care, and home care services.

First off, congratulations to the IHUB BIEL board, which is approaching 1000 followers. I admire many of the people who post there, although I am not a member myself. I am leery of the negative emotions the social media circus triggers, and since I would most likely be banned in about 5 minutes, it’s pointless.

I do thank the long time posters there, many of whom I have linked to on this blog so readers here could benefit.

However, let’s face a sobering truth, nobody really knows about the ActiPatch. It has never “gone viral”. We’ve had a couple of nibbles, and a lot of people who were desperate and seeking pain relief stumbled on to it, and that is a big part of why Bioelectonics (BIEL) is still a story. The ActiPatch works.

Also, nobody really knows about this company. Everyone is in the market, but this is usually through a 401K plan. Nobody buys subpennies. Your broker will laugh at you. He is paid to laugh at you. It’s a total sheeple mentality. If you can remember 2008, when all the “smart money” stocks got obliterated due to widespread economic fraud, you may take “smart money” with a grain of salt. We need to get more shareholders for this value based stock with a great pipeline and concept.

So, we have a relatively unknown product and a relatively unknown stock, after years of noble effort on IHUB by some of the best, smartest, and most creative people on the Internet.

Where am I going?

Fidget Spinners.

Yes, you read that right. I had never heard of a Fidget Spinner in my life until Baron Trump (what a name) got off the Presidential helicopter playing with a fidget spinner. Suddenly they were everywhere, gas stations had them, quickie marts, etc.

Twitter did that. Baron went viral on Twitter and other social media and fidget spinners became a thing.

So, get on Twiter and follow Bioelectronic VP of Sales Keith Nalepka. He gets it. Follow all the Bioelectronic people, and retweet their news announcements. You will find this rewarding–these are very smart people. Also, there are multitudes of people sincerely trying to get relief from pain safely.

I don’t know how many people are on Twitter. A hundred million? For the loyal IHUBers–the best day of our investment lives is when we finally lose any control over this stock and technology. There have been days when I have had a good percentage of the stock’s volume–how is that even possible? So, lets get behind Nalepka’s effort and start pushing this on Twitter.

Keith Nalepka Retweeted HHS.gov

we have been innovating, look paid for by the NHS in the UK, proven in trials to lower medication use, fewer doctor visits, sold in 29 countries, its time for the US market to see the light, large retailers are taking notice, oh and its OTC.

Keith Nalepka added,

Not a great day. Weak sales translated into an opportunity for people to short the stock to the tune of a 25% drop.

Not pleasant, but wasn’t this whole run up fueled by a  short squeeze on traders who were caught by surprise when the NHS announced subsidized payments on the ActiPatch? These guys make the market.

The expression “keep your eye on the prize”. Where you want to be on the day the FDA announces General Clearance is  sitting on a couple million shares of BIEL. The first two FDA clearances were not long after a successful FDA meeting. This is where the new lawyers for BIEL explained to the FDA why the ActiPatch should be OTC.

As per Andrew Whelan, once BIEL gets that third clearance (Back) this will translate into a General Clearance. General Clearance is your money melon, and the main reason I am troubling myself to hold on to this stock.

Let’s see what BIEL has to say after the May 29th FDA meeting. 8 trading days left till it, then maybe 2 to develop a press release.

After this stock hits, the next stop is physical silver. I mean to stay poor, even after I get rich.  Poverty is your treasure, don’t lose it, as the Buddhist koan goes. Silver is a ticking time bomb.  The Implosion in 2008 was partially fueled by the wheels coming off the silver rig. Buying mining stocks is pointless. Just get physical.  Plus, BIEL has taught me something–I hate the stock market. I aim to get rid of that third party risk.

Since JP Morgan will be rigging silver for the foreseeable future, I can wait for BIEL to outwait the FDA, who must eventually run out of excuses. I think TENS has more at stake in stopping BIEL then the dreaded Opioid cartel at this point.

Winding up May 15th, 2018.  Bioelectronics will most likely release a statement about the May 29th FDA meeting by June 1st, 2018.  While BIEL cannot comment on the General Clearance meeting which took place on May 9th (or so) while in process, it might well provide some hints included in the May 29th release on the separate FDA application for wound healing. This would be the tactful way.

Waiting for  the “ink to dry” on the Doctor Scholl’s agreement. I have a pen here at home I could have lent them, usually  dries completely in about thirty seconds. I admit it is not a very special pen, I think I lifted it from a bank, but I would have been happy to donate it, for future reference.

 

This is interesting

(Thanks to TAZZER from the IHUB board).

I interpret this to mean we are at Day 60, proceeding with the Interactive Review.

Hope this individual is correct.

 

Expedited Access Pathway Program

The FDA recently published draft guidance on the Breakthrough Devices program. You can submit your comments on the draft guidance, which describes the policies that the agency intends to use to implement the program, by December 26, 2017.

On December 13, 2016, the Breakthrough Devices provisions were added to the Food, Drug, and Cosmetic Act through section 3051 of the 21st Century Cures Act. This program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives.

The Breakthrough Devices Program expands upon the Expedited Access Pathways (EAP) program by making future 510(k)s eligible as well as Premarket Approval applications (PMA) and De Novo device submissions. All participants previously granted EAP designation will have designation as Breakthrough Devices; no separate action is necessary.

For any questions about the Breakthrough Devices program or EAP, please contact CDRHExpeditedAccessPathway@fda.hhs.gov.

The Expedited Access Pathway (EAP) program is a voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA), premarket notification (510[k]) or requests for De Novo designation. The program is detailed in the FDA’s guidance Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.

Under EAP, the FDA works with device sponsors to try to reduce the time and cost from development to marketing decision without changing the FDA’s PMA approval standard of reasonable assurance of safety and effectiveness, the standards for granting De Novo requests, or any other standards of valid scientific evidence.

Components of the program include priority review, more interactive review, senior management involvement, and assignment of a case manager. The extent to which the FDA provides these features depends on the availability of resources.

Participation in the EAP program is only at the request of the sponsor and with the FDA’s agreement. If the FDA determines that a device may be eligible for this program and the sponsor has not yet submitted a Pre-Submission (Pre-Sub) requesting EAP Designation, the FDA intends to inform the sponsor of the program. For details on how to request feedback from the FDA, see FDA’s Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff Guidance for Industry and Food and Drug Administration Staff.

Devices eligible for EAP Designation

Devices subject to premarket approval applications (PMAs), premarket notification (510[k]) or requests for De Novo designation are eligible for EAP designation if the following criteria are met:

  1. Provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.

AND

  1. The device meets at least one of the following criteria:
    1. Represent breakthrough technologies;
    2. No approved or cleared alternatives exist;
    3. Offer clinically meaningful advantages over existing approved or cleared alternatives including the potential, when compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or
    4. The availability of which is in the best interest of patients.

When to Request EAP Designation

The FDA strongly recommends sponsors interested in participating in this voluntary program contact the FDA early in the development of their device. In most cases, a sponsor should request EAP designation prior to beginning an IDE pivotal study so the FDA and the sponsor can make sure the data being collected in the pivotal study are appropriate to include in the device’s marketing submission.

Sponsors who are developing a device that may qualify for EAP designation and would like to be considered for the program should submit a Pre-Sub following the procedures described below and explained in detail in the EAP guidance.  The FDA encourages sponsors to contact the appropriate division/branch to alert them of their plan to submit a request for EAP Designation prior to submitting it or at the time of submission.

Submitting a request for EAP designation

The request for EAP designation should be a standalone submission (i.e., no other requests are included with the request for EAP designation) and submitted as a Pre-Sub to the appropriate Center’s Document Control Center. The current mailing address for CDRH’s DCC and a link to CBER’s DCC’s mailing address are provided on the eCopy Program for Medical Device Submissions webpage.

Pre-Subs are not subject to a user-fee. However, you must submit an eCopy (per section 745(A)(b) of the FD&C Act).  For information about how to comply with the eCopy program, please see the FDA’s guidance document eCopy Program for Medical Device Submissions.

Submissions should be written in the English language. Any material in a foreign language should be accompanied by an accurate and complete English translation.

Content of a submission requesting EAP designation

A Pre-Sub requesting EAP designation should include the following information:

  • Cover Letter clearly noting the purpose of the Pre-Sub stated as: “Request for Inclusion in the Expedited Access Pathway Program, as described in the Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions Guidance, issued on April 13, 2015″ and a statement of whether you believe you are eligible as a PMA or de novo candidate.
  • Table of Contents
  • Device Description
  • Proposed Intended Use/Indications for Use
  • A discussion of how your device meets the EAP eligibility criteria
    • Include a discussion of why the device meets the EAP criteria described in section III.C of the EAP guidance, including any relevant supporting documentation
  • A draft Data Development Plan (Optional)
    • A description and summary of the data collection plan, including study synopses and study design.
      • Outline of nonclinical & clinical testing, planned or already completed
      • Proposed Labeling
      • Summary of Nonclinical Studies, including study design & protocol, as available
      • Summary of Clinical Studies, proposed or completed
    • Explanation and justification for the proposed balance of premarket and postmarket data collection, if applicable.
    • A timeline for the development and marketing of the device, and for the postmarket data collection, if applicable.

The Agency developed two Data Development Plan examples, Example 1 and Example 2 to offer a format for the organization of the information in a draft Data Development Plan.

These examples are equivalent and differ only in formatting. The information provided in these examples does not create new requirements or expectations for affected parties, nor are they intended to convey FDA’s recommended approaches or guidance. Rather, these are examples of how the Data Development Plan information recommended in the EAP guidance could be organized.

FDA Response to requests for EAP designation

  • The FDA intends to notify the sponsor of its determination in writing within 30 days of receipt of a request for EAP designation.
  • If there is insufficient information for the FDA to make a decision about EAP designation, the FDA may request the sponsor submit additional information.
  • In response to such request, any additional information provided by the sponsor should be submitted as a supplement to the Pre-Sub.
    • If the FDA requests additional information from the sponsor, the FDA will notify the sponsor in writing whether or not EAP designation is granted within 30 days of the date of the request for additional information.
    • If the FDA has not received enough information in time to make a decision by 30 days after a request for additional information is sent, the FDA intends to deny the EAP designation.

Benefit-Risk considerations

The FDA’s Benefit-Risk Guidance explains the principal factors that the FDA considers when making benefit-risk determinations in the premarket review of certain medical devices, including devices subject to PMAs. Two of the factors that the FDA may consider as part of making benefit-risk determinations are postmarket data collection and uncertainty.

The FDA may accept a greater degree of uncertainty of the benefit-risk profile for these devices if the uncertainty is sufficiently balanced by other factors, including the probable benefits for patients to have earlier access to EAP Devices (e.g., devices that treat a life-threatening disease when no alternative treatments are available), and adequate postmarket controls to support premarket approval.

As part of the FDA’s benefit-risk determination, the FDA intends to weigh the device’s impact on patient health, including the probable benefit of earlier access to the device, against the probable risk of harm to patients from the device should subsequent data collection demonstrate that the device is ineffective or unsafe.

Role of Postmarket Data for EAP Devices Subject to PMA

As part of the EAP program, the FDA intends to work interactively with the sponsor within the benefit-risk framework discussed in the FDA’s Benefit-Risk Guidance and in accordance with statutory and regulatory requirements, to determine whether certain data may be collected postmarket rather than premarket.

Getting the right balance between premarket and postmarket data collection – specifically, where appropriate, a greater reliance on postmarket collection – can reduce the extent of premarket data submission and directly impact when patients will have access to high-quality, safe and effective medical devices.

Section 513(a)(3)(C) of the FD&C Act requires the FDA to consider the use of postmarket controls in lieu of collecting and reviewing all effectiveness data prior to PMA approval.  In addition, section 513(a)(3)(D)(ii) of the FD&C Act (the “least burdensome provision”) specifically provides:

Any clinical data, including one or more well-controlled investigations, specified in writing by the Secretary for demonstrating a reasonable assurance of device effectiveness shall be specified as a result of a determination by the Secretary that such data are necessary to establish device effectiveness.  The Secretary shall consider, in consultation with the applicant, the least burdensome appropriate means of evaluating device effectiveness that would have a reasonable likelihood of resulting in approval.

The consideration of postmarket information as part of premarket review is discussed in the FDA’s Benefit-Risk Guidance as one of the principal factors that the FDA considers when making benefit-risk determinations during the premarket review for devices subject to PMA, and is consistent with the FDA’s guidance The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles (“Least Burdensome Guidance”), issued October 4, 2002.

Postmarket requirements as conditions of approval for PMAs under the EAP program

The FDA intends to impose postmarket requirements, including requiring post-approval studies, as a condition of approval for devices subject to a PMA when applicable.

EAP designation denials

Even if your device does not qualify for EAP designation, you can utilize the pre-submission process to request feedback from the FDA. Please see FDA’s Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff Guidance for Industry and Food and Drug Administration Staff for details on how to request feedback from the FDA.

EAP designation revocation

An EAP designation will not be revoked solely because a similar product is approved or a de novo request granted. The FDA may revoke an EAP Designation at any time prior to approval upon written notice to the sponsor if the FDA determines that:

  • Based on information available, the device is no longer eligible for an EAP Designation according to the EAP criteria outlined in Section III.A of the guidance; or
  • The information submitted in support of a request for EAP Designation, including, without limitation, the Pre-Sub package, or any related premarket submission contained an untrue statement of material fact or omitted material information, including false statements relating to data collection.

As a general matter, the FDA does not intend to revoke EAP Designation for other reasons.

A fairly ideal outcome for this press release-These applications are very template driven, the hard part was the creative effort to invent this and get through all the other hurdles.

IHUB is going to get ugly near term until the recent spate of orchestrated stock shorters throw in the towel. Last FDA approvals, it took several days for the stock to really spike. I think this news needs to sink in, be understood and digested by the investing world.

No new testing required and the previous 510K submission can be used. Approval for the back means full OTC General Clearance. Migraine, Menstrual, Carpal Tunnel, everything can go easier, not to mention post surgery coming up on May 29th.

 

BioElectronics Receives FDA Pre-Submission Approval for its Relief of Musculoskeletal Pain Market Clearance Application

GlobeNewswire

FREDERICK, MD , May 11, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to report on the outcome of its Pre-Submission meeting on May 9th, 2018 with the US Food and Drug Administration (US FDA). The FDA’s Pre-Submission Program is designed to organize and give guidance and feedback on clinical data and what regulatory pathway should be followed to get market clearance. The focus of the May 9 pre-submission meeting was in discussing the FDA’s feedback on the clinical outcomes and statistical techniques used in reporting the back-pain study.  

Upon reviewing pre-submission information on the ActiPatch® back-pain study (https://clinicaltrials.gov/ct2/show/NCT03240146), the FDA provided positive feedback on the clinical results, and guidance on a 510(k) submission to obtain expanded market clearance for over-the-counter (OTC) treatment of musculoskeletal pain. This would make ActiPatch available as a drug-free, safe, pain relief option for the 126 million Americans (one in two adults) who are suffering with some form of musculoskeletal pain. While ActiPatch is already FDA cleared for treatment of pain from knee osteoarthritis (25 million) and plantar fasciitis (1 million annually), expanded market clearance would allow additional products for the back (42 million), neck (19 million), hip (9 million), shoulder (11 million), carpal tunnel (12 million) and many other musculoskeletal complaints.

The company was represented by their clinical R&D team comprising: Sree Koneru, Ph.D., VP Product Development, Ian Rawe, Director Clinical Research of BioElectronics, Kenneth McLeod, Ph.D. Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D. Professor Duke University. Dr. Koneru, who led the discussion, expressed confidence in the FDA’s constructive feedback. “We are pleased that the FDA viewed our data and statistical methods favorably. They have provided guidance on how to combine the back-pain study results, along with our previously cleared 510(k), into a single 510(k) submission for obtaining expedited expanded market clearance.”, he said.

An additional pre-submission meeting is scheduled with the FDA on May 29th, 2018 to seek expanded indications in a separate application for OTC treatment of pain and edema following surgical procedures for its RecoveryRx® medical device.

About BioElectronics Corporation